510(k) · Cleared
ClearedMedefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medefil, Inc. · NGT Saline, Vascular Access Flush
Cleared on Jun 20, 2002 as substantially equivalent to K993515 (Medefil, Inc., 2000) after an 84-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jun 20, 2002
- Review
- 84 days
- Class
- Class II
- Product code
- NGT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993515 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK993515 Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML…Medefil, Inc. · 2000
- This deviceK020999 Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML…Medefil, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK091583 Medefil's Normal Saline I.V. Flush SyringeMedefil, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 0 of its ownK121262 Medeflush Normal Saline I.V. Flush Syringe-Sterile Field ReadyMedefil, Inc. · 2012
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993515 | Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3… | Medefil, Inc. | 2000 | — |
| 0 (this device) | K020999 | Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6… | Medefil, Inc. | 2002 | — |
| +1 | K091583 | Medefil's Normal Saline I.V. Flush Syringe | Medefil, Inc. | 2010 | 1 |
| +2 | K121262 | Medeflush Normal Saline I.V. Flush Syringe-Sterile Field Ready | Medefil, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NGT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NGT device
- #1 K250884 0.9 % Sodium Chloride Injection, USP, BD…score 11.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993515 | Medefil's Normal Saline Flush Syringe, in Various Fill Sizes - 1 ML Fill in 3 ML Syringe…Summary page 3…below: Medefil, Inc. Normal Saline I. V. Flush Syringe (K993515) The Medefil’s Normal Saline Flush Syringe Device is similar to the legally marketed predicate device in that: both have… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091583 | Medefil's Normal Saline I.V. Flush Syringe | 2010 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K091583 (Medefil, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All NGT devicesNGT Saline, Vascular Access Flush: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NGT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NGT
142in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NGT
1in 2025
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · NGT
212in 2025
MAUDE reports naming product code NGT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 31 |
| 2008 | 1 | — | 0 | 64 |
| 2009 | 1 | — | 1 | 18 |
| 2010 | 2 | — | 7 | 23 |
| 2011 | 3 | 219 | 1 | 20 |
| 2012 | 4 | 106 | 1 | 5 |
| 2013 | 1 | — | 1 (1) | 25 |
| 2014 | 3 | 87 | 0 | 25 |
| 2015 | 1 | — | 0 | 14 |
| 2016 | 1 | — | 1 (1) | 82 |
| 2017 | 2 | — | 0 | 56 |
| 2018 | 1 | — | 0 | 270 |
| 2019 | 2 | — | 2 | 340 |
| 2020 | 2 | — | 0 | 322 |
| 2021 | 0 | — | 1 (1) | 566 |
| 2022 | 3 | 151 | 1 | 282 |
| 2023 | 6 | 142 | 3 (2) | 313 |
| 2024 | 1 | — | 0 | 332 |
| 2025 | 1 | — | 1 | 212 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING
INTRAVENOUS ACCESS DEVICES (IVAD)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020999 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020999: Medefil's Normal Saline Flush Syringe in Various Fill Sizes - 1 ML Fill in 6 ML Syringe LL; 2 ML Fill in 6 ML Syringe LL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020999
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026